Complying with healthcare standards and legal regimes in Asia can be a major hurdle. Indeed, recent years have seen a number of cases where corporations have suffered heavy fines for various breaches, prominent among them the fining of a multinational British pharma company for 3 billion yuan (US$460m) in China on counts of corruption. Outside of this case and across the region, governments are stepping up regulation to monitor the healthcare industry. Baker McKenzie’s Vivian Wu and Ben McLaughlin provide tips and tactics to comply with healthcare laws, mitigate risks, and avoid litigation.
Successfully navigating Asia's healthcare space starts with a robust internal compliance program. However, such efforts go well beyond the bounds of the corporation and includes a deep-rooted investigation into managing compliance risks associated with third-party intermediaries. This involves thorough compliance due diligence of business partners and associates in target markets to ensure they have adequate compliance programs of their own and a clean record on bribery issues.
As data becomes the lifeblood of innovation in healthcare, corporations should regularly check and audit their policies on data privacy, protection and compliance. They should also know data protection rules within their operating jurisdictions as they pertain to: cross-border transfer of data and risks; strictness and enforcement of data privacy laws; and remaining compliant with new regulations, especially when it comes to network-connected medical devices and the storage of related data.
KNOW DATA PROTECTION LAWS INSIDE AND OUT
PERFORM REGULAR CORPORATE HEALTH CHECKS
Risk assessment is a very important component of successful compliance programs, and it goes far beyond routine employee training. A full "health check" must be performed on the company, and such checks often benefit with insights from external consultants. Especially if compliance breaches occur, it can be prudent to consult advisors for a new perspective and solutions to rooting out the cause of the problem and proposing a strategy to move forward.
PRIORITIZE COMPLIANCE WITH ANTI-BRIBERY AND CORRUPTION LAWS
ACQUIRING PATENTS OR MEDTECH? IMPLEMENT THOROUGH IP DUE DILIGENCE
Verifying intellectual property can prevent setbacks post-close. In any transaction involving healthcare IP, make sure you are securing the rights to all relevant inventions, patents, and distribution rights. Third-party patent rights preventing use post acquisition can clearly defeat the very purpose of the transaction. It is important to properly scope the IP due diligence at the outset and following the completion of the deal.
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Healthcare STEPS FOR SUCCESS: Upping the dosage of compliance and due diligence
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